Catheter Engineer

Catheter Engineer Remedy Robotics San Francisco, CA Job Details Full-time 2 hours ago Qualifications FDA submissions Medical device testing ISO standards Production validation processes Compliance documentation Regulatory submission editing and review Biomedical regulatory compliance Biomedical manufacturing processes Manufacturing company experience Product design documentation Full Job Description Remedy Robotics is a medical technology company developing robotic systems for endovascular intervention. Its proprietary technology combines robotics, machine learning, and advanced computer vision to help physicians perform highly precise endovascular procedures and expand access to life-saving stroke and cardiovascular care. Initially focused on neurovascular intervention, Remedy is addressing the limited availability of specialized treatment for time-critical cardiovascular emergencies, with the long-term goal of enabling expert intervention regardless of patient location. Headquartered in San Francisco, Remedy is backed by DCVC, Blackbird, and Tony Fadell's Build Collective, among others. We are seeking an experienced Catheter Engineer to own the design, development, and regulatory approval of a broad range of catheter-based medical devices. This is a high-impact, hands-on role for a technically deep engineer who thrives at the intersection of product development, regulatory strategy, and cross-functional project leadership.

What You'll Do:

Design & Development Lead end-to-end design and engineering of steerable catheter products, from concept through commercialization. Author and own design specifications, design history files (DHFs), risk analyses (FMEA/FTA), and verification & validation protocols. Define and document design inputs and outputs in alignment with

FDA 21 CFR

Part 820 and

ISO 13485

quality systems. Select materials, manufacturing processes, and design architectures appropriate for catheter performance, biocompatibility, and manufacturability - with a strong eye toward DFM/DFA. Own BOM structure and routing management; maintain accurate manufacturing records in compliance with

ISO 13485.

Design Transfer & Manufacturing Ramp Lead structured design transfer to contract manufacturing partners, ensuring manufacturing requirements are clearly defined, documented, and controlled. Drive process validation programs (IQ/OQ/PQ) from protocol authorship through execution and report approval. Conduct DFM/DFA reviews throughout development to ensure designs are manufacturable at target cost and quality levels. Build and qualify the supplier base for steerable catheter components; manage ongoing supplier quality including incoming inspection criteria and corrective actions. Regulatory & Quality Coordinate V&V testing programs - write protocols, oversee execution, and author test reports that meet FDA submission standards. Maintain and update technical files and DHFs to support audits, NCRs, and post-market surveillance. Proactively identify and mitigate regulatory risks throughout the product development lifecycle. Contract Manufacturing & Supply Chain Serve as the primary technical interface with contract manufacturing partners. Drive component sourcing, vendor qualification, and supply risk management for catheter subassemblies and raw materials. Manage supplier quality requirements including incoming inspection and corrective action processes. Project Management Own project plans, milestones, and resource coordination across design, regulatory, manufacturing, and quality workstreams. Manage budgets and timelines for development programs from prototype builds through first commercial shipment. Coordinate product launch logistics including labeling, packaging validation, sterility testing, and distribution readiness. Provide regular project status updates to leadership; escalate risks and drive decisions proactively. Minimum Qualifications 5+ years of medical device engineering experience with a strong focus on catheter or flexible tubular device development. Demonstrated track record of taking a steerable catheter through FDA regulatory clearance or approval (510(k) or equivalent) as the lead engineer - not a supporting contributor. Hands-on experience authoring DHFs, V&V protocols, IQ/OQ/PQ documentation, and regulatory submission technical sections. Proven experience managing contract manufacturers for catheter assembly. Deep familiarity with

FDA 21 CFR

Part 820, ISO 13485, and

ISO 14971.

Nice to Have Experience with balloon catheter design or multi-lumen extrusion Hydrophilic and lubricious coating specification and qualification Laser cutting processes for catheter components Biocompatibility testing (ISO 10993) CAD proficiency (SolidWorks or equivalent)